Bowel Preparation, Efficacy, Tolerability, SafetyPhase 4NCT07605897

Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives

A Phase 4 study testing Use of a standardized meal content (food-kit) the day prior to colonoscopy and Polyethylene glycol 3350 - electrolyte solution (GoLYTELY) in people with Bowel Preparation, Efficacy, Tolerability, Safety and Colon Cancer Screening, run by Joseph Spataro at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep. Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy. Read more about this study

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Bowel Preparation, Efficacy, Tolerability, Safety, Colon Cancer Screening, Bowel Preparation for Colonoscopy
What is being tested?: Use of a standardized meal content (food-kit) the day prior to colonoscopy and Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2022to 24 Jun 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)

Who cannot join

Personal history of colorectal cancer
Inflammatory bowel disease
Prior colon resection
Antithrombotic therapy precluding polypectomy
Pregnancy
Hospitalization at the time of the scheduled procedure

Show all 10Show fewer

Celiac disease (food kit contained gluten products)
Prior colonoscopy (cognitive bias)
Chronic kidney disease stage 3 or higher
Age 70 years or older.

Trial locations and contacts

1 site in 1 country.

United States1 site

Central Virginia VA Health Care System
Richmond, Virginia, 23249

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population

The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.

Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.

Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.

Conditions: Bowel Preparation, Efficacy, Tolerability, Safety, Colon Cancer Screening, Bowel Preparation for Colonoscopy
Being tested: Use of a standardized meal content (food-kit) the day prior to colonoscopy, Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)
Keywords: colonoscopy, bowel preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Use of a standardized meal content (food-kit) the day prior to colonoscopyOther
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)Drug
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.

Study groups in NCT07605897
Study group	Role	What they receive
Experimental: Food Kit with Laxatives (Happy Colon Foods)	Experimental	Patients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions. Receives: Other: Use of a standardized meal content (food-kit) the day prior to colonoscopy
Control: Standard GoLYTELY Split-Dose Prep	Active comparator	Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy. Receives: Drug: Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient acceptance/satisfaction
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
Measured: Periprocedural

Secondary outcomes (3)

Quality of bowel preparation
Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9. Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups.
Measured: During colonoscopy (single procedure)
Patient-reported symptoms during bowel preparation
Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing).
Measured: Periprocedural
Adverse events during bowel preparation
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202224 Jun 2025

First posted26 May 2026
Study start1 Nov 2022
Primary completion24 Jun 2025
Study completion24 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Bowel Preparation, Efficacy, Tolerability, SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Feasibility study comparing low-fiber vs clear-liquid diet before colonoscopy
Masking: Single blind
Who is masked: Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07605897
Sponsor's protocol ID: IRBNet ID: 1689988
Status last verified: May 2026
First submitted: 11 May 2026
Last updated: 26 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism. Aggregate results will be disseminated through presentations and peer-reviewed publications.

Publications

Lahti H, Lyyra N, Hietajarvi L, Villberg J, Paakkari L. Profiles of Internet Use and Health in Adolescence: A Person-Oriented Approach. Int J Environ Res Public Health. 2021 Jun 29;18(13):6972. doi: 10.3390/ijerph18136972.
PubMed 34209886
Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
PubMed 28282690
Tyson SF, Burton L, McGovern A. The impact of a toolkit on use of standardised measurement tools in stroke rehabilitation. Clin Rehabil. 2015 Sep;29(9):926-34. doi: 10.1177/0269215514562590. Epub 2014 Dec 11.
PubMed 25501626
Hafeez M, Yuan C, Shahzad K, Aziz B, Iqbal K, Raza S. An empirical evaluation of financial development-carbon footprint nexus in One Belt and Road region. Environ Sci Pollut Res Int. 2019 Aug;26(24):25026-25036. doi: 10.1007/s11356-019-05757-z. Epub 2019 Jun 27.
PubMed 31250390
Othman F, Crooks CJ, Card TR. The risk of Clostridium difficile infection in patients with pernicious anaemia: a retrospective cohort study using primary care database. United European Gastroenterol J. 2017 Nov;5(7):959-966. doi: 10.1177/2050640617695697. Epub 2017 Feb 21.
PubMed 29163961
Chak A, Cooper GS, Canto MI, Pollack BJ, Sivak MV Jr. Enteroscopy for the initial evaluation of iron deficiency. Gastrointest Endosc. 1998 Feb;47(2):144-8. doi: 10.1016/s0016-5107(98)70347-5.
PubMed 9512279
Vetter B, Gasch B, Padosch SA. [Coping with complex medical emergency situations : Competent and successful decision-making, communication and leadership]. Anaesthesist. 2015 Apr;64(4):298-303. doi: 10.1007/s00101-015-2423-2. German.
PubMed 25701067
Smith MM, Hayes AJ, Melrose J. Pentosan Polysulfate, a Semisynthetic Heparinoid Disease-Modifying Osteoarthritic Drug with Roles in Intervertebral Disc Repair Biology Emulating the Stem Cell Instructive and Tissue Reparative Properties of Heparan Sulfate. Stem Cells Dev. 2022 Aug;31(15-16):406-430. doi: 10.1089/scd.2022.0007. Epub 2022 Mar 14.
PubMed 35102748
Hu S, Gong T, Ma J, Tao Y, Xian Q. Simultaneous determination of iodinated haloacetic acids and aromatic iodinated disinfection byproducts in waters with a new SPE-HPLC-MS/MS method. Chemosphere. 2018 May;198:147-153. doi: 10.1016/j.chemosphere.2018.01.124. Epub 2018 Feb 3.
PubMed 29421724
Rotolo F, Vitiello V, Pellegrini D, Carotenuto Y, Buttino I. Historical control data in ecotoxicology: Eight years of tests with the copepod Acartia tonsa. Environ Pollut. 2021 Sep 1;284:117468. doi: 10.1016/j.envpol.2021.117468. Epub 2021 May 27.
PubMed 34062440
Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102
Raulf-Heimsoth M, Rihs HP, Rozynek P, Cremer R, Gaspar A, Pires G, Yeang HY, Arif SA, Hamilton RG, Sander I, Lundberg M, Bruning T. Quantitative analysis of immunoglobulin E reactivity profiles in patients allergic or sensitized to natural rubber latex (Hevea brasiliensis). Clin Exp Allergy. 2007 Nov;37(11):1657-67. doi: 10.1111/j.1365-2222.2007.02833.x. Epub 2007 Sep 19.
PubMed 17883426
Robertson GS, Ristic CD, Bullen BR. The incidence of congenitally absent foot pulses. Ann R Coll Surg Engl. 1990 Mar;72(2):99-100.
PubMed 2185683
Kahl S, Zimmermann S, Genz I, Glasbrenner B, Pross M, Schulz HU, Mc Namara D, Schmidt U, Malfertheiner P. Risk factors for failure of endoscopic stenting of biliary strictures in chronic pancreatitis: a prospective follow-up study. Am J Gastroenterol. 2003 Nov;98(11):2448-53. doi: 10.1111/j.1572-0241.2003.08667.x.
PubMed 14638347
Parsons TM, Satchithananda K, Berbe R, Siddiqui IA, Robinson E, Hart AJ. [MRI investigations in patients with problems due to metal-on-metal implants]. Orthopade. 2013 Aug;42(8):629-36. doi: 10.1007/s00132-012-2036-2. German.
PubMed 23912305

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population
ClinicalTrials.gov ID: NCT07605897
Acronym / sponsor ID: IRBNet ID: 1689988
Conditions: Bowel Preparation, Efficacy, Tolerability, Safety, Colon Cancer Screening, Bowel Preparation for Colonoscopy
Keywords: colonoscopy, bowel preparation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Joseph SpataroUS federal agency
Collaborators: Happy Colon Foods
Study start: 1 Nov 2022 (actual)
Primary completion: 24 Jun 2025 (actual)
Study completion: 24 Jun 2025 (actual)
First posted: 26 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.

Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.

Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Feasibility study comparing low-fiber vs clear-liquid diet before colonoscopy

Arm	Type	Receives
Experimental: Food Kit with Laxatives (Happy Colon Foods)	Experimental	Other: Use of a standardized meal content (food-kit) the day prior to colonoscopyPatients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions.
Control: Standard GoLYTELY Split-Dose Prep	Active comparator	Drug: Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)

Key exclusion criteria (10 listed)

Personal history of colorectal cancer
Inflammatory bowel disease
Prior colon resection
Antithrombotic therapy precluding polypectomy
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Use of a standardized meal content (food-kit) the day prior to colonoscopyLow-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy	Other	Experimental: Food Kit with Laxatives (Happy Colon Foods)
Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.	Drug	Control: Standard GoLYTELY Split-Dose Prep

Primary outcome

Patient acceptance/satisfaction
Time frame: Periprocedural
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.

3 secondary outcomes

Quality of bowel preparation
Time frame: During colonoscopy (single procedure)
Patient-reported symptoms during bowel preparation
Time frame: Periprocedural
Adverse events during bowel preparation
Time frame: Periprocedural

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Background: PubMed 34209886Lahti H, Lyyra N, Hietajarvi L, Villberg J, Paakkari L. Profiles of Internet Use and Health in Adolescence: A Person-Oriented Approach. Int J Environ Res Public Health. 2021 Jun 29;18(13):6972. doi: 10.3390/ijerph18136972.
Background: PubMed 28282690Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
Background: PubMed 25501626Tyson SF, Burton L, McGovern A. The impact of a toolkit on use of standardised measurement tools in stroke rehabilitation. Clin Rehabil. 2015 Sep;29(9):926-34. doi: 10.1177/0269215514562590. Epub 2014 Dec 11.
Background: PubMed 31250390Hafeez M, Yuan C, Shahzad K, Aziz B, Iqbal K, Raza S. An empirical evaluation of financial development-carbon footprint nexus in One Belt and Road region. Environ Sci Pollut Res Int. 2019 Aug;26(24):25026-25036. doi: 10.1007/s11356-019-05757-z. Epub 2019 Jun 27.
Background: PubMed 29163961Othman F, Crooks CJ, Card TR. The risk of Clostridium difficile infection in patients with pernicious anaemia: a retrospective cohort study using primary care database. United European Gastroenterol J. 2017 Nov;5(7):959-966. doi: 10.1177/2050640617695697. Epub 2017 Feb 21.
Background: PubMed 9512279Chak A, Cooper GS, Canto MI, Pollack BJ, Sivak MV Jr. Enteroscopy for the initial evaluation of iron deficiency. Gastrointest Endosc. 1998 Feb;47(2):144-8. doi: 10.1016/s0016-5107(98)70347-5.
Background: PubMed 25701067Vetter B, Gasch B, Padosch SA. [Coping with complex medical emergency situations : Competent and successful decision-making, communication and leadership]. Anaesthesist. 2015 Apr;64(4):298-303. doi: 10.1007/s00101-015-2423-2. German.
Background: PubMed 35102748Smith MM, Hayes AJ, Melrose J. Pentosan Polysulfate, a Semisynthetic Heparinoid Disease-Modifying Osteoarthritic Drug with Roles in Intervertebral Disc Repair Biology Emulating the Stem Cell Instructive and Tissue Reparative Properties of Heparan Sulfate. Stem Cells Dev. 2022 Aug;31(15-16):406-430. doi: 10.1089/scd.2022.0007. Epub 2022 Mar 14.
Background: PubMed 29421724Hu S, Gong T, Ma J, Tao Y, Xian Q. Simultaneous determination of iodinated haloacetic acids and aromatic iodinated disinfection byproducts in waters with a new SPE-HPLC-MS/MS method. Chemosphere. 2018 May;198:147-153. doi: 10.1016/j.chemosphere.2018.01.124. Epub 2018 Feb 3.
Background: PubMed 34062440Rotolo F, Vitiello V, Pellegrini D, Carotenuto Y, Buttino I. Historical control data in ecotoxicology: Eight years of tests with the copepod Acartia tonsa. Environ Pollut. 2021 Sep 1;284:117468. doi: 10.1016/j.envpol.2021.117468. Epub 2021 May 27.
Background: PubMed 19136102Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
Background: PubMed 17883426Raulf-Heimsoth M, Rihs HP, Rozynek P, Cremer R, Gaspar A, Pires G, Yeang HY, Arif SA, Hamilton RG, Sander I, Lundberg M, Bruning T. Quantitative analysis of immunoglobulin E reactivity profiles in patients allergic or sensitized to natural rubber latex (Hevea brasiliensis). Clin Exp Allergy. 2007 Nov;37(11):1657-67. doi: 10.1111/j.1365-2222.2007.02833.x. Epub 2007 Sep 19.
Individual participant dataSharing planned: No. Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism. Aggregate results will be disseminated through presentations and peer-reviewed publications.

Related trials for Bowel Preparation, Efficacy, Tolerability, Safety

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Not yet recruitingEarly Phase 1
A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient acceptance/satisfaction (time frame: Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07605897, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.